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Medical aid scheme Discovery Health CEO Ryan Noach has emphasised the importance of Phase 3 clinical trial data on Covid-19 vaccines, urging manufacturers to produce trial evidence alongside assurance to the general public.
Speaking during a virtual webinar on Thursday, he explained that the Serum Institute of India will dispatch the initial batch of 1-million Oxford University/AstraZeneca vaccine doses on February 1, with the vaccination of 1.25-million South African health workers the target once the follow-up batch is dispatched.
“What is important is the Phase 3, which is called the double blinded randomised trial, where human subjects at large scale, to achieve statistical relevance, must receive either prescriber or vaccine, without the subject or the doctor knowing what they are receiving. They must demonstrate two outcomes from the Phase 3 trial: trial 1 that the vaccine is safe and trial 2 the vaccine is effective. The safety and efficacy data emerges from the Phase 3 trials, which leads to approval,” he added.
He explained that the AstraZeneca vaccine is built on the adenoviral vector platform, which is a tried and tested method used for many other kinds of vaccines, over many tens of years, emphasising its safety.
He added that Johnson & Johnson vaccines are important for countries like South Africa, as it is a single dose vaccine compared with other approved vaccines, which are double dose vaccines. It can also be kept stable at typical refrigeration levels.
He touched on the Sinopharm vaccine, saying neither Russia or China have produced any Phase 3 clinical trial data, despite claims that they did. He pointed out that the data was never published, it is not available for inspection, it has not been submitted to regulators for approval and no one knows about its safety and efficacy, despite assurances from manufacturers that it is safe.
He explained that as a clinician, he did not take assurance from manufacturers without evidence.
“We must see evidence before we advocate for taking any particular vaccine or administer it to any of our patients or colleagues,” he said.
Covid-19 Vaccines Explored
Noach explained that there were close to 200 Covid-19 vaccines being explored in lab experiments.
“The biotech world has done us an enormous favour as humanity in moving so fast and being able to apply prior learnings to a lot of this vaccine development. It is amazing that all these years into the HIV epidemic, we still do not have an HIV vaccine. We are fortunate in a way and we should consider ourselves fortunate that just over a year into the Covid-19 pandemic we have some vaccines emerging,” he noted.
Ten vaccines are already approved and licensed, with a further 22 in Phase 3 of clinical trials.
He raised some concern with the Moderna and BioNTech companies, which use the messenger RNA technology. Noach said because the technology has never been used before, there is no long-term understanding of how this technology affects the body or the safety data showing that it is completely safe.
“The focus of a lot our work at the moment through the task teams that we are working in, supporting the Department of Health, is to try and get more vaccines before June, about 10-million doses. We would like to vaccinate the higher risk people sooner,” Noach said.
He reinforced the safety of approved vaccines, which will not only have individual and public health benefits, but also an immediate impact on the economy.